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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: Mice, CBA/CaOlaHsd
Sex:
female
Vehicle:
propylene glycol
Concentration:
A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which can be technically used, was a 25% suspension in propylene glycol. Vortexing of the test item was used to formulate the test item.

Thus, the test item in the main study was assayed at 5, 10, and 25% (w/w). The highest concentration tested was the highest level that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed in the pre-experiment.
No. of animals per dose:
5
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Test item concentration Mean DPM per animal (2 lymph nodes) a) SD S.I. Vehicle Control Group (PG) 1113.5 321.3 1.00 5% Macrolex Gelb G 6273.1 857.0 5.63 10% Macrolex Gelb G 6225.9 1228.1 5.59 25% Macrolex Gelb G 5079.3 1439.8 4.56
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Calculation and Results of Individual Data Vehicle: PG Test item concentration DPM values measured DPM-BG per animal (2 lymph nodes) a) S.I.b) % Group no. Animal no. --- --- BG I 17 --- --- --- --- BG II 20 --- --- 0 1 1 889 870.5 --- 0 1 2 977 958.5 --- 0 1 3 1153 1134.5 --- 0 1 4 1680 1661.5 --- 0 1 5 961 942.5 --- 5 2 6 6124 6105.5 5.5 5 2 7 5798 5779.5 5.2 5 2 8# 7775 7756.5 7.0 5 2 9 5628 5609.5 5.0 5 2 10 6133 6114.5 5.5 10 3 11 4900 4881.5 4.4 10 3 12 6416 6397.5 5.7 10 3 13 5278 5259.5 4.7 10 3 14 6616 6597.5 5.9 10 3 15 8012 7993.5 7.2 25 4 16 3566 3547.5 3.2 25 4 17 7283 7264.5 6.5 25 4 18 5680 5661.5 5.1 25 4 19 4296 4277.5 3.8 25 4 20 4664 4645.5 4.2 # = Outlier as detected by Dean-Dixon- and Grubb’s Test. The value in question (animal no. 8) was not excluded from the calculations, since exclusion of the outlier did not change the overall result. 1 = Control Group 2-4 = Test Group a) = values corrected for mean background value (BGI and BGII) b) = Stimulation Indices relative to the mean of the control group (Group 1)

Viability / Mortality

No deaths occurred during the study period.

Clinical Signs

The animals did not show any signs of local skin irritation during the course of the study and no cases of mortality were observed. On day 1, one animal (no. 14), treated with the test item concentration of 10%, showed a bulging eye (right side). The other animals of that test group and the animals treated with 5 and 25% test item concentration did not show any signs of systemic toxicity. Redness of the ear skin could not be observed, due to the colour of the test item.

Body Weights

The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.

Executive summary:

In the study the test item Macrolex Gelb G formulated in PG was assessed for its possible skin sensitising potential.

For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (w/w).

The animals did not show any signs of local skin irritation during the course of the study and no cases of mortality were observed. On day 1, one animal (no. 14), treated with the test item concentration of 10%, showed a bulging eye (right side). The other animals of that test group and the animals treated with 5 and 25% test item concentration did not show any signs of systemic toxicity. Redness of the ear skin could not be observed, due to the colour of the test item.

In this study Stimulation Indices (S.I.) of 5.63, 5.59, and 4.56 were determined with the test item at concentrations of 5, 10, and 25% (w/w) in PG, respectively.

The test item Macrolex Gelb G was found to be a skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one was tested in a LLNA and Stimulation Indices (S.I.) of 5.63, 5.59, and 4.56 were determined with the test item at concentrations of 5, 10, and 25% (w/w) in PG, respectively.

In another skin sensitization test conducted according to the Buehler protocol no clear sensitization was observed with induction concentrations of 83% and chalange concentrartions of 83, 75, 50 or 25%.


Migrated from Short description of key information:
3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is sensitizing in guildeline Local Lymph Node Assay (LLNA) in mice.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is sensitizing in guildeline Local Lymph Node Assay (LLNA) in mice with SI values above 3 for compound concentrations at and above 5%. No clear sensitization was observed in a Buehler test with induction concentrations of 83% and chalange concentrartions of 83, 75, 50 or 25%.

Overall, the compound will be classified as R43 according to DSD and Skin. Sens. Cat 1B according to GHS.